Implant success and safety of left atrial appendage closure with the WATCHMAN device: peri-procedural outcomes from the EWOLUTION registry

Abstract

Aims Left atrial appendage closure is a non-pharmacological alternative for stroke prevention in high-risk patients with non-valvular atrial fibrillation. The objective of the multicentre EWOLUTION registry was to obtain clinical data on procedural success and complications, and long-term patient outcomes, including bleeding and incidence of stroke/transient ischaemic attack (TIA). Here, we report on the peri-procedural outcomes of up to 30 days. Methods and results Baseline/implant data are available for 1021 subjects. Subjects in the study were at high risk of stroke (average CHADS 2 score: 2.8 ± 1.3, CHA 2 DS 2 -VASc: 4.5 ± 1.6) and moderate-to-high risk of bleeding (average HAS-BLED score: 2.3 ± 1.2). Almost half of the subjects (45.4%) had a history of TIA, ischaemic stroke, or haemorrhagic stroke; 62% of patients were deemed unsuitable for novel oral anticoagulant by their physician. The device was successfully deployed in 98.5% of patients with no flow or minimal residual flow achieved in 99.3% of implanted patients. Twenty-eight subjects experienced 31 serious adverse events (SAEs) within 1 day of the procedure. The overall 30-day mortality rate was 0.7%. The most common SAE occurring within 30 days of the procedure was major bleeding requiring transfusion. Incidence of SAEs within 30 days was significantly lower for subjects deemed to be ineligible for oral anticoagulation therapy (OAT) compared with those eligible for OAT (6.5 vs. 10.2%, P = 0.042). Conclusion Left atrial appendage closure with the WATCHMAN device has a high success rate in complete LAAC with low peri-procedural risk, even in a population with a higher risk of stroke and bleeding, and multiple co-morbidities. Improvement in implantation techniques has led to a reduction of peri-procedural complications previously limiting the net clinical benefit of the procedure.

2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS

“…Zabieg implantacji może być przyczyną poważnych powikłań [446,[456][457][458], a w analizach baz danych firm ubezpieczeniowych oraz przeglądach systematycznych stwierdzano dużą częstość występowania takich incydentów, co być może wskazuje na pewnego stopnia błąd selektywnego raportowania wyników [446,456]. W niedawnym dużym rejestrze europejskim stwierdzono dużą częstość powodzenia implantacji (98%) z możliwą do zaakceptowania częstością występowania powikłań związanych z zabiegiem, wynoszącą 4% w ciągu 30 dni [459]. U większości pacjentów, którzy w przeszłości zostaliby uznani za niekwalifikujących się do OAC, wyniki współcześnie prowadzonego leczenia przeciwzakrzepowego wydają się stosunkowo dobre [396,407,460].…”

“…PRZEDSIONKA W CELU ZAPOBIEGANIA UDAROM MÓZGU Najczęstszym uzasadnieniem stosowania urządzeń do zamykania LAA w praktyce klinicznej jest postrzegane duże ryzyko krwawienia, a rzadziej przeciwwskazania do OAC [459]. Niestety, urządzeń do zamykania LAA nie zbadano w takich populacjach.…”

Role of Imaging in Left Atrial Appendage Occlusion

“…In the presence of peri-device leak ≥5mm, resuming or pursuing antithrombotic therapy or further intervention may be considered. However, the clinical impact of peri-device leak is unknown with no clear relationship with adverse events [3,4,34].…”

“…Management consist mostly on short-term anticoagulation. Recently, Main et al have proposed consensus echocardiographic diagnostic criteria for DAT diagnosis: echo density on the LA aspect of the device (1) not explained by imaging artefact; (2) inconsistency with normal healing/device incorporation; (3) visible in multiple TOE planes, (4) in contact with the LAA occluder device; and (5) exhibiting independent motion [53]. CCTA is also able to detect DAT or thrombus on the adjacent LA wall [32].…”

“…Two randomized-controlled trials, the PROTECT AF and PRE-VAIL studies, have shown the safety and efficacy of this procedure in patients randomized to either LAA closure with the WATCHMAN device (Boston Scientific, Natick, MA, USA) or warfarin therapy [1,2]. Two large registries in patients who were mostly contra-indicated or deemed unsuitable to long-term anticoagulation and treated with the Amplatzer Cardiac Plug (ACP) (St. Jude Medical/Abbott, St Paul, MN, USA) (ACP multicenter registry) [3] or the WATCHMAN (Ewolution registry) [4] have confirmed safety and efficacy of this procedure in this population. Currently, the European Society of Cardiology (ESC) guidelines for the management of AF recommend that LAA closure may be considered in patients with high-risk of stroke and contraindications to long-term OAC (class IIb, level of evidence B) [5].…”